Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

NCT04865133 | Completed

• 2 other identifiers: 21-001818NCI-2021-03137
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.

Conditions

COVID-19 Infection; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals

  Wilcoxon rank sum test will be used to compare between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).

  Up to 12 months

Secondary Outcomes (2)

• Adverse events of COVID-19 vaccines in cancer patients and health individuals

  Up to 12 months

• T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals

  Up to 12 months

Other Outcomes (1)

• Incidence and severity of COVID-19 infection after the vaccination in cancer patients and health individuals

  Up to 12 months

Study Arms (1)

Observational (biospecimen collection, medical record)

Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection, medical record)

Electronic Health Record Review OTHER

Medical record reviewed

Observational (biospecimen collection, medical record)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with cancer on or will be starting on systemic cytotoxic chemotherapy for their cancer and healthy individuals who will receive COVID-19 vaccine

You may qualify if:

• Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)
• Willing and able to provide research blood samples
• Capable of providing valid informed consent
• For cancer patient cohort:
• Male or female age \>= 18 years
• Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
• For healthy individual cohort:
• Male or female age \>= 18 years
• No history of active malignancy =\< 3 years
• EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
• NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =\< 3 years
• PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
• PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
• PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age \>= 18 years
• PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody

You may not qualify if:

• Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

COVID-19

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Saranya Chumsri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 29, 2021
• Study Start: March 31, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (1)